Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study)

NCT02043795 | Completed

• 1 other identifier: 2013/539/C
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.

Conditions

Critical Limb Ischemia

Keywords

Bioresorbable Vascular Scaffold System; Percutaneous Transluminal Angioplasty; Stent

Outcome Measures

Primary Outcomes (1)

• Change in Re-stenosis rates between 6 months and 12 months

  defined at stenosis \>=50% of the treated segment on duplex ultrasound, CT angiography or MR angiography

  6 months and 12 months

Secondary Outcomes (6)

• Change in Mean Transcutaneous oxygen measurement (TCOMs) between 6 months and 12 months

  6 and 12 months

• Change in Amputation free survival between 6 months and 12 months

  6 months and 12 months

• Change in Freedom from Target lesion revascularization between 6 months and 12 months

  6 and 12 months

• Change from baseline in Rutherford class at 6 months and 12 months

  Baseline, 6 and 12 months

• Number of Participants with major adverse limb events (MALE)

  within 1 year

Other Outcomes (1)

• Sensitivity and specificity of each imaging modality

  1 year

Study Arms (1)

Treated with BVS

OTHER

Symptomatic patients would be screened with a duplex ultrasound as per clinical practice prior to intervention. After informed consent for a standard angiography/intervention, the patient will undergo a planned intervention under general or local anaesthesia in an angiographic facility.

Device: BVS, Abbott Vascular

Interventions

BVS, Abbott Vascular DEVICE

The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular).

Also known as: Bioresorbable Vascular Scaffold System

Treated with BVS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stenotic (\> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
• A maximum of 2 target lesions in one or more infrapopliteal vessels
• Minimum of 1mm overlap of stents
• Reference vessel diameter should be 2-4.0 mm
• Symptomatic critical limb ischemia (Rutherford 4, 5, 6)
• The patient must be \> 21 years of age
• Life-expectancy of more than 12 months
• The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
• The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
• The patient must provide written patient informed consent

You may not qualify if:

• Patient refusing treatment
• The reference segment diameter is not suitable for available stent design
• Unsuccessfully treated (\>50% residual stenosis) proximal inflow limiting arterial stenosis
• Untreatable lesion located at the distal outflow arteries
• Lesion location requiring kissing stent procedure
• The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
• The patient takes Phenprocoumon (Marcumar).
• The patient is currently breast-feeding, pregnant or intends to become pregnant.
• Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
• Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure to the target vessel

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Steven Kum, MD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: January 23, 2014
• Study Start: July 1, 2013
• Primary Completion: March 19, 2018
• Study Completion: February 1, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

SG (1)